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A Randomized, Phase III Study of Lenvatinib in Chinese Patients with Radioiodine-Refractory Differentiated Thyroid Cancer.

Department of Thyroid and Neck Tumor, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China. Department of Head and Neck Surgical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Department of Head and Neck Surgery, Fudan University Shanghai Cancer Center, Shanghai, China. Department of Head and Neck Surgery, Zhejiang Cancer Hospital, Hangzhou, China. Thyroid Tumor Internal Medicine Department, Hunan Cancer Hospital, Changsha, China. Department of Thyroid and Neck, Henan Cancer Hospital, Henan, China. Department of Nuclear Medicine, Nanjing First Hospital, Nanjing, China. Department of Thyroid Surgery, The First Hospital of Jilin University, Jilin, China. Department of Head and Neck Surgery, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China. Department of Nuclear Medicine, West China School of Medicine/West China Hospital, Sichuan University, Sichuan, China. Department of Nuclear Medicine, Tianjin Medical University General Hospital, Tianjin, China. Department of Breast and Thyroid Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Department of Nuclear Medicine, First Hospital of Shanxi Medical University, Shanxi, China. Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Shanghai, China. Department of Nuclear Medicine, Peking Union Medical College Hospital, Beijing, China. Department of Head and Neck Surgical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China. Japan and Asia Clinical Development Department, Oncology Business Group, Eisai Co., Ltd., Tokyo, Japan. Clinical Data Science Department, Medicine Development Center, Eisai Co., Ltd., Tokyo, Japan. Department of Thyroid and Neck Tumor, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, China. gaoming68@aliyun.com. Tianjin Union Medical Center, Tianjin, China.

Clinical cancer research : an official journal of the American Association for Cancer Research. 2021;(20):5502-5509
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Abstract

PURPOSE Lenvatinib has shown efficacy in treating radioiodine-refractory differentiated thyroid cancer (RR-DTC) in the multinational phase III SELECT study; however, it has not been tested in Chinese patients with RR-DTC. PATIENTS AND METHODS Chinese patients with confirmed RR-DTC (n = 151) were randomly assigned 2:1 to receive lenvatinib 24 mg/day or placebo in 28-day cycles. The primary endpoint was progression-free survival, and key secondary endpoints included objective response rate and safety. Analyses for progression-free survival and objective response rate were conducted using Response Evaluation Criteria in Solid Tumors v1.1 and confirmed by independent imaging review. All adverse events were assessed and monitored. RESULTS Progression-free survival was significantly longer with lenvatinib treatment [n = 103; median 23.9 months; 95% confidence interval (CI), 12.9-not estimable] versus placebo (n = 48; median 3.7 months; 95% CI, 1.9-5.6; hazard ratio = 0.16; 95% CI, 0.10-0.26; P < 0.0001). The objective response rate was 69.9% (95% CI, 61.0-78.8) in the lenvatinib arm and 0% (95% CI, 0-0) in the placebo arm. At data cutoff, 60.2% of patients receiving lenvatinib remained on treatment; treatment-emergent adverse events led to lenvatinib discontinuation in 8.7% of patients. Overall, treatment-emergent adverse events of grade ≥3 occurred in 87.4% of patients in the lenvatinib arm, the most common being hypertension (62.1%) and proteinuria (23.3%). CONCLUSIONS Lenvatinib at a starting dose of 24 mg/day significantly improved progression-free survival and objective response rate in Chinese patients with RR-DTC versus placebo. There were no new or unexpected toxicities. Results are consistent with those from SELECT involving patients with RR-DTC.

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